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Wednesday, April 22, 2009

PhRMA is extending its ban on lavish entertainments from sales contacts with clinical practitioners to the contact between sponsors and clinical trial investigators.

The trade association of the biggest U.S. drug companies, the Pharmaceutical Research & Manufacturers of America, unveiled a new version of its “Principles on Conduct of Clinical Trials” on April 20. Part of the principles call for drug companies to apply PhRMA’s new Puritanism to dealings with clinical investigators.

No more nice resorts to plan clinical trials or bring together investigators. The “Principles” specifically define the types of location and entertainment that will be acceptable for clinical trial teams to get together. “Resorts are not appropriate venues,” the Principles state bluntly.

“While modest meals or receptions may be appropriate during company-sponsored meetings with investigators, companies should not provide recreational or entertainment events in conjunction with those meetings,” the business-like code declares.

And guests are not welcome: “It is not appropriate to pay honoraria or travel or lodging expenses for those who are not involved in the clinical trial.”

The clinical trials principles essentially adopt the same restrictions on entertainment applied by PhRMA to marketing contacts in a separate code adopted last summer.

And the reasoning is clear again. PhRMA’s President Billy Tauzin has a politician’s innate sense of the right argument for the right climate: now is no time to flaunt lavish entertainment of customers or clinical trial investigators. This is a time for the business to adopt a parsimonious demeanor – of course, the new frugality does not extend to lobbying expenses where PhRMA is extending its giving to new constituencies like labor consultants (but that’s a different story).

And these changes in entertaining patterns will slowly affect the cost structure of the industry – skinning away some of the marketing/entertaining fat. That’s not an untimely change for an industry that is losing some of its biggest revenue producers.

The new version of the clinical trial principles is the third update for the voluntary code, which was first adopted by the industry in 2001. The newest version of the code can be called the “disclosure edition” because its primary purpose is to address the key issues of public openness about the existence of specific trials, the results of trials, and a clearer definition of the roles played by each named contributor in published results.

There are important commitments to openness about listing trials and trial results from the drug companies – and some equally important exclusions about the types of trials that PhRMA does not believe its members should have to post on the government trials database. PhRMA does not believe, for example, that it helps patients to tell the public about the existence of Phase I research.

The code is simple and defines a more open clinical trial process and one with less unseemly influence (in the form of entertainment, etc.) on investigators. From that perspective, it is an improvement. Whether it will be enough to restore the public confidence in the accuracy and unbiased results of trials is a question of a different magnitude.

4 comments:

One of the key reasons for creating ClinicalTrials.gov was the desire to provide hope to patients suffering from serious or life-threatening illnesses by expanding their access to information about ongoing clinical trials for life-saving therapies.

PhRMA agrees with this mission and we believe that the National Institutes of Health should focus on expanding access to registry and results information on clinical trials involving patients who require medical care.

Some Phase 1 studies in patients will be disclosed; our member companies have made that commitment and many are already doing so. Those interventional trials are most important to patients who may benefit from the experimental treatment under study and the physician who may prescribe it.

Ken Johnson, Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President

Thank you both for your comments. Here are some links to relevant documents: the PhRMA press release (http://www.phrma.org/news_room/press_releases/revised_clinical_trial_principles_reinforce_phrma%92s_commitment_to_transparency/); a list of comments to NIH on the clinical trial registry, including comments from PhRMA, BIO, GPhA; Pfizer, Abbott and Consumer’s Union (http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=NIH-2009-0002).

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